Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 98d10756-e523-4ce7-b076-20c08271e4bf
Route
CUTANEOUS
Published
Effective Date 2010-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium (4.64 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-06-01

Description

Active Ingredient: TITANIUM DIOXIDE


Medication Information

Description

Warnings:

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Rash or irritation develops and lasts.



Directions:

Apply evenly before sun exposure and as needed.

Children under 6months of age; ask a doctor.

Section 51727-6

Inactive Ingredients:



BETULA PLATYPHYLLA JAPONICA JUICE, CYCLOPENTASILOXANE, GLYCERIN, DICAPRYLYL CARBONATE, ORYZA, SATIVA (RICE) BRAN OIL, ETHYLHEXYL PALMITATE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIMETHICONE, MAGNESIUM SULFATE, METHYL

METHACRYLATE CROSSPOLYMER, CYCLOMETHICONE, DISTEARDIMONIUM HECTORITE, POLYGLYCERYL-4 ISOSTEARATE, TRIHYDROXYSTEARIN, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, TRIMETHYLSILOXYSILICATE, PHENYL TRIMETHICONE, IRON OXIDES (CI 77492), CAPRYLIC/CAPRIC GLYCERIDES,   ETHYLHEXYLGLYCERIN, DIMETHICONE CROSSPOLYMER, IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), ALUMINUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE,  FRAGRANCE, GLYCERYL CAPRYLATE, STEARIC ACID, SILICA SILYLATE, CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, CITRUS AURANTIFOLIA (LIME) OIL, MANNAN, RIBES NIGRUM (BLACK CURRANT) SEED OIL, ROSA DAMASCENA FLOWER OIL, ILLICIUM VERUM (ANISE) FRUIT/SEED OIL, WATER, PINUS PINASTER WOOD EXTRACT, BUTYLENE GLYCOL, ROSA GALLICA FLOWER EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, PADINA PAVONICA THALLUS EXTRACT, ORIGANUM MAJORANA LEAF EXTRACT, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, PSEUDOALTEROMONAS FERMENT EXTRACT, GENTIANA SCABRA ROOT EXTRACT, LYCIUM CHINENSE ROOT

EXTRACT, KOCHIA SCOPARIA FRUIT EXTRACT, NELUMBO NUCIFERA LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT



Section 51945-4

Section 55106-9

Active Ingredient: TITANIUM DIOXIDE


Structured Label Content

Description (34089-3)

Warnings:

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Rash or irritation develops and lasts.



Directions:

Apply evenly before sun exposure and as needed.

Children under 6months of age; ask a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients:



BETULA PLATYPHYLLA JAPONICA JUICE, CYCLOPENTASILOXANE, GLYCERIN, DICAPRYLYL CARBONATE, ORYZA, SATIVA (RICE) BRAN OIL, ETHYLHEXYL PALMITATE, POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIMETHICONE, MAGNESIUM SULFATE, METHYL

METHACRYLATE CROSSPOLYMER, CYCLOMETHICONE, DISTEARDIMONIUM HECTORITE, POLYGLYCERYL-4 ISOSTEARATE, TRIHYDROXYSTEARIN, DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, TRIMETHYLSILOXYSILICATE, PHENYL TRIMETHICONE, IRON OXIDES (CI 77492), CAPRYLIC/CAPRIC GLYCERIDES,   ETHYLHEXYLGLYCERIN, DIMETHICONE CROSSPOLYMER, IRON OXIDES (CI 77491), IRON OXIDES (CI 77499), ALUMINUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE,  FRAGRANCE, GLYCERYL CAPRYLATE, STEARIC ACID, SILICA SILYLATE, CITRUS GRANDIS (GRAPEFRUIT) PEEL OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, CITRUS AURANTIFOLIA (LIME) OIL, MANNAN, RIBES NIGRUM (BLACK CURRANT) SEED OIL, ROSA DAMASCENA FLOWER OIL, ILLICIUM VERUM (ANISE) FRUIT/SEED OIL, WATER, PINUS PINASTER WOOD EXTRACT, BUTYLENE GLYCOL, ROSA GALLICA FLOWER EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, PADINA PAVONICA THALLUS EXTRACT, ORIGANUM MAJORANA LEAF EXTRACT, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, PSEUDOALTEROMONAS FERMENT EXTRACT, GENTIANA SCABRA ROOT EXTRACT, LYCIUM CHINENSE ROOT

EXTRACT, KOCHIA SCOPARIA FRUIT EXTRACT, NELUMBO NUCIFERA LEAF EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT



Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Active Ingredient: TITANIUM DIOXIDE


Advanced Ingredient Data


Raw Label Data

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